预约演示
更新于：2026-09-07
Forimtamig
更新于：2026-09-07
概要
基本信息
原研机构- |
非在研机构- |
权益机构- |
最高研发阶段临床1/2期 |
首次获批日期- |
最高研发阶段(中国)临床申请批准 |
特殊审评- |
登录后查看时间轴
结构/序列
Sequence Code 565381979
来源: *****
Sequence Code 565382263
来源: *****
Sequence Code 682564950
来源: *****
Sequence Code 682564951
来源: *****
关联
2
项与 Forimtamig 相关的临床试验NCT06055075
An Open-Label, Randomized Phase IB/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
NCT04557150
An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig (RO7425781) in Participants With Relapsed or Refractory Multiple Myeloma
100 项与 Forimtamig 相关的临床结果
登录后查看更多信息
100 项与 Forimtamig 相关的转化医学
登录后查看更多信息
100 项与 Forimtamig 相关的专利（医药）
登录后查看更多信息
6
项与 Forimtamig 相关的文献（医药）2026-09-01CLINICAL PHARMACOLOGY & THERAPEUTICS
Patient‐Centric First‐in‐Human Dose Selection: An Ex Vivo Minimal Anticipated Biological Effect Level Approach for T‐Cell Engagers in Multiple Myeloma
Article
作者: Bscheider, Michael ; Blanco, Laura ; Steiner, Guido ; Rossmann, Eva ; Giusti, Anna Maria ; Azpiroz, Aintzane Zabaleta ; Schneider, Anneliese ; Jacob, Wolfgang ; Fauti, Tanja ; Paiva, Bruno ; Marrer‐Berger, Estelle ; Haegel, Helene ; Belli, Sara ; Frances, Nicolas ; Kraft, Thomas E. ; Martinet, Ludovic ; Weisser, Martin
The minimal anticipated biological effect level (MABEL) approach to first‐in‐human (FIH) dose calculation can lead to long dose‐escalation periods before observing clinical activity. We used a novel
ex vivo
MABEL approach to calculate the FIH starting dose for forimtamig, a T‐cell bispecific antibody under investigation for the treatment of relapsed/refractory multiple myeloma (RRMM). We used
in vitro
and
ex vivo
MABEL approaches to calculate the FIH dose for a Phase 1 trial (NCT04557150) in patients with RRMM.
In vitro
assays used the OPM‐2 MM cell line and peripheral blood mononucleocytes from healthy donors and patients with MM.
Ex vivo
assays used fresh bone marrow aspirates from MM patient donors. Forimtamig increased tumor cell lysis, cytokine release, and T‐cell activation
in vitro
and
ex vivo
. Tumor cell lysis was considered the most relevant assay for dose calculation. EC
50
for LDH release (
in vitro
: mean 0.6 pM;
ex vivo
: 9 pM for the most sensitive patient) led to calculated FIH starting doses of 0.4 and 6 μg, respectively. FIH starting dose was 6 μg. Clinical activity was observed in the second dosing cohort (18 and 54 μg). The third dosing cohort (54 and 162 μg) showed durable objective responses. Cytokine release syndrome was Grade 1 at the starting dose and absent in the second dosing cohort. Our
ex vivo
MABEL approach was accepted by regulatory authorities and yielded a tolerated forimtamig FIH starting dose which demonstrated clinical activity in the second dosing cohort. We encourage similar innovative patient‐centric approaches to FIH dose calculation.
2026-06-01Annals of Medicine and Surgery
Forimtamig: a potent GPRC5D-targeted bispecific antibody in multiple myeloma
作者: Asad, Maham ; Ali, Hafsa ; Hilal, Hiba ; Jaber Amin, Mohammed Hammad ; Gul, Maliha
Multiple myeloma is a malignancy of clonal plasma cells characterized by progressive bone marrow infiltration, commonly presenting with anemia, bone pain, hypercalcemia, and renal dysfunction. T-cell bispecific antibodies (TCBs) have emerged as an effective therapeutic option in relapsed and refractory multiple myeloma, with G-coupled protein receptor, family C, group 5, member D (GPRC5D) representing a promising target due to its high expression in myeloma cells and limited presence in normal tissues. Forimtamig is a next-generation GPRC5D-targeting TCB with a novel 2:1 binding format – bivalently engaging GPRC5D and monovalently binding CD3ε on T cells. This structural advantage enhances avidity, stabilizes immunological synapses, and enables potent T-cell activation and cytotoxicity, even against low-antigen-expressing cells in immunosuppressive bone marrow environments. Preclinical studies show that forimtamig outperforms earlier 1 + 1 TCB formats by 50–200-fold in cell-killing efficiency. When combined with standard agents such as daratumumab, pomalidomide, or cereblon E3 ligase modulatory drugs, forimtamig has shown improved tumor clearance and reduced relapse rates. Its design also minimizes tumor escape by targeting the N-terminal region of GPRC5D. Currently undergoing phase 1 trials, forimtamig is being evaluated both as monotherapy and in combination regimens. Its high potency, favorable safety, and durable immune engagement make it a promising candidate in the evolving treatment landscape of multiple myeloma.
2025-12-31mAbs
T cell margination: investigating the detour of T cells following forimtamig treatment in humanized mice
Article
作者: Lechner, Stefanie ; Crisand, Cylia ; Bröske, Ann-Marie E. ; Osl, Franz ; Attig, Jan ; Colombetti, Sara ; Mueller, Joerg P.J. ; Klein, Christian ; O’Brien, Nils ; Beilhack, Andreas ; Eckmann, Jan ; Wolf, Ann-Katrin ; Pöschinger, Thomas ; Umaña, Pablo ; Rae, Richard
T cell bispecific antibodies (TCBs) are a promising new class of therapeutics for relapsed/refractory multiple myeloma. A frequently observed, yet incompletely understood effect of this treatment is the transient reduction of circulating T cell counts, also known as T cell margination (TCM). After administration of the GPRC5D-targeting TCB forimtamig (RG6234), TCM occurred in patients and correlated with cytokine release and soluble B cell maturation antigen decrease. We demonstrate that TCM is accurately represented in the humanized NSG mouse model and occurs at a lower threshold of target expression than systemic cytokine release. Application of whole-mouse tissue clearing and 3D imaging revealed that T cells accumulate in the bone marrow after treatment. We hypothesize that low amounts of targets are sufficient to rapidly redirect T cells upon TCB engagement. Therefore, we propose TCM as a beneficial, highly sensitive and early effect of forimtamig that leads T cells to likely sites of bone marrow tumor lesions.
100 项与 Forimtamig 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12724 | - | - | - |
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 难治性多发性骨髓瘤 | 临床2期 | 澳大利亚 | 2023-12-12 | |
| 难治性多发性骨髓瘤 | 临床2期 | 加拿大 | 2023-12-12 | |
| 难治性多发性骨髓瘤 | 临床2期 | 意大利 | 2023-12-12 | |
| 难治性多发性骨髓瘤 | 临床2期 | 新西兰 | 2023-12-12 | |
| 难治性多发性骨髓瘤 | 临床2期 | 韩国 | 2023-12-12 | |
| 难治性多发性骨髓瘤 | 临床2期 | 西班牙 | 2023-12-12 | |
| 复发性多发性骨髓瘤 | 临床1期 | 澳大利亚 | 2020-11-11 | |
| 复发性多发性骨髓瘤 | 临床1期 | 比利时 | 2020-11-11 | |
| 复发性多发性骨髓瘤 | 临床1期 | 丹麦 | 2020-11-11 | |
| 复发性多发性骨髓瘤 | 临床1期 | 法国 | 2020-11-11 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 163 | 鏇壓鏇遞願鹽廠鹹糧鹽(構憲願壓顧淵齋繭衊構) = 齋鹽膚襯繭廠餘齋壓鏇 蓋衊鬱選醖齋憲選廠網 (襯鹹製遞鬱鹽淵壓選願, 0 ~ 100) 更多 | - | 2023-12-09 | |||
临床1期 | 120 | 艱壓獵鹽選餘遞網鬱願(窪襯醖餘艱積願壓繭選) = 選廠襯壓選網鑰繭製選 襯餘廠觸願獵築選鹹壓 (廠築窪簾顧夢築觸齋憲 ) 更多 | - | 2023-09-26 | |||
临床1期 | 105 | (Intravenous) | 鹽簾壓膚鬱製鬱遞簾齋(鏇艱夢繭壓壓襯繭網鏇) = Gr ≥3 hematologic AEs were infrequent (anemia: IV 13.7%, SC 5.2%; thrombocytopenia: IV 13.8%, SC 18.5%; neutropenia: IV 11.8%, SC 16.7%) 壓廠構艱蓋鬱壓觸遞齋 (鹹繭壓築齋築壓簾鬱範 ) 更多 | 积极 | 2022-11-15 | ||
(Subcutaneous) | |||||||
临床1期 | 41 | 網衊夢鬱網製鏇艱窪夢(醖糧積蓋淵糧構製艱築) = CRS occurred in 85.4% of pts (G1 56.1%, G2 24.4%, G3 2.4%). Three pts (7.3%) experienced CNS toxicity related to RG6234 (G1 and G3 headache; G1 confusion). G3/4 neutropenia, thrombocytopenia, and anemia occurred in 9.8%, 19.5%, and 12.2% of pts, respectively. 築膚艱鏇襯淵餘構築簾 (範遞遞遞獵窪鏇積鹽壓 ) 更多 | 积极 | 2022-05-12 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用